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Dipeptidyl Peptidase-4 (DPP-4) Inhibitor

Saxagliptin 5 mg (B) for Type 2 Diabetes

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Awards & highlights

Study Summary

The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A1C Changes From Baseline at Week 24 - Open Label Cohort
Hemoglobin A1c (A1C) Changes From Baseline at Week 24
Secondary outcome measures
Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)
Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort
Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)
+3 more
Other outcome measures
All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period
All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort
Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort
+27 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Saxagliptin 5 mg (B)Experimental Treatment3 Interventions
Metformin 500-2000 mg (as needed for rescue)
Group II: Saxagliptin 2.5 mg (A)Experimental Treatment3 Interventions
Metformin 500-2000 mg (as needed for rescue)
Group III: Saxagliptin 10 mg (C)Experimental Treatment3 Interventions
Metformin 500-2000 mg (as needed for rescue)
Group IV: Open-Label Treatment Cohort (Direct Enrollees) (E)Experimental Treatment2 Interventions
Saxagliptin 10 mg Metformin 500-2000 mg (as needed for rescue)
Group V: Placebo (D)Placebo Group2 Interventions
Metformin 500-2000 mg (as needed for rescue)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo matching Metformin
2005
Completed Phase 3
~1040
Saxagliptin
FDA approved
Metformin
FDA approved

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,302 Previous Clinical Trials
288,623,564 Total Patients Enrolled
~52 spots leftby Jun 2025
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